Cardiovascular disease is a leading cause of morbidity and mortality, particularly in the United States and in Western European countries and is emerging in developing countries. Several factors are mentioned relation to the development of cardiovascular disease including hereditary predisposition to the disease, gender, lifestyle factors such as smoking and diet, age, hypertension, and hyperlipidemia, including hypercholesteremia. Several of these factors, particularly hyperlipidemia and hypercholesteremia, contribute to the development of atherosclerosis, a primary cause of vascular and heart disease.
Elevated low-density lipoprotein cholesterol (hereafter “LDL-cholesterol”) is directly related to an increased risk of coronary heart disease.
The presence of soy protein in food consumed by humans is associated with a lower level of low-density lipoprotein cholesterol (LDL-cholesterol) and lower risk of coronary heart disease.
Food products comprising soy protein are well known. Examples of food products that may comprise soy protein are meat products, baked products, food analogs and dairy products. Types of soy proteins and food uses of soy proteins are described in Waggle, D. H. and Kolar, C. W., Soy protein and human nutrition, proceedings of a symposium held May 222-25, 1978 in Keystone Colourado, pages 19-51.
Soy protein materials are known to reduce total cholesterol and LDL-cholesterol levels in the blood of animals. An analysis of the effects of soy protein intake on serum lipids in humans has shown that dietary soy protein is significantly related to lowering serum concentrations of total cholesterol and LDL-cholesterol in humans (Anderson, Johnstone, and Cook-Newell, N. Engl. J. Med., Vol. 333, No. 5, pp. 276-82 (1995)).
Statins are compounds that are known to have a lowering effect on levels of LDL-cholesterol in the human blood. Statins inhibit the hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase, the rate-determining step in the cholesterol biosynthesis.
Scientific research has confirmed the healthy properties of statins especially with respect to LDL blood-cholesterol and triglyceride levels lowering activities, both in animals and in humans (Li et al., Nutrition Research 18, 71-81 (1998); Heber et al., Am. J. Clin. Nutr. 69, 231-236 (1999)).
Early reports of the effect of statins were made in 1979. The Japanese scientist Endo isolated a metabolite from Monascus that reduced artificially induced hyperlipoproteinemia in rats (Endo, J. Antibiotics 32, 852-854, (1979)). These metabolites are known as monacolins. Monacolin is identical to the cholesterol lowering pharmaceutical lovastatin. Lovastatin is sold by Merck co. under the tradename Mevacor. A derivative of lovastatin, simvastatin, is sold as a cholesterol-lowering drug under the name of Zocor. Other derivatives of lovastatin e.g. pravastatin, and mevastatin, are also sold as lipid lowering drugs against hypercholesterolemia. Monascus-extracts are sold in capsules in Japan as the dietary product Monacolin. The usual dose of the above statins is 20 mg/day, which results in at least 20% blood LDL-cholesterol lowering.
The production of statins is also reported in fermentation using fungi other than the above-mentioned Monascus species. It has been shown that statins can be produced by a variety of filamentous fungi, including Monascus, Aspergillus, Penicillium, Pleurotus, Pythium, Hypomyces, Paelicilomyces, Eupenicillium, and Doratomyces. 
The preparation and purification of the statins used in pharmaceutical preparations involves many process-steps, in which ingredients are used that are not commonly used in the food industry. The many process steps increase costs compared to processes having less process steps. For these reasons the statins prepared for pharmaceutical use are not used in the foods industry.
As a food product, rice fermented with a red Monascus fungus (red rice) has been known and used for hundreds of years in China. Red rice was used and still is used in wine making, as a food-colouring agent and as drug in traditional Chinese medicine. We have found that most red rice available on the market contains no statins or statins in very low amounts. The Food and Drug Administration has concluded that red yeast rice available in the market does not contain significant amounts of lovastatin (FDA, Docket No. 97-0441, Final Decision).
WO 99/23996 describes a composition for treating elevated serum cholesterol and/or triglycerides comprising a red rice product containing at least 0.05% lovastatin by weight.
Red rice powder capsules are sold as dietary supplements under the name of Cholestin by the firm Pharmanex. Pharmanex also sells a Cholestin bar containing red yeast rice (Monascus purperus went).
Red rice has an intensive red color. Whereas the intensive red colour of red rice is an advantage when it is used as colouring agent, it is a disadvantage when it is used in the majority of food products. Due to the intense red colour of red-rice products, the foods prepared from red rice are coloured, depending on the amount of red-rice product added to the food product yellow, orange or red. The higher the amount of red rice added to the food, the more intense is the red colour of the food product. In the known food products a relatively large amount of red rice has to be added in order to add enough statins. This results in a red color of the products that cannot be avoided.
In some food products the red rice coloring is undesirable. In particular in the western world, consumers are reluctant to use products of which the color has changed from that they are used to. For example spreads, including margarine, butter, low fat spreads and cooking or salad oils are considered unacceptable by customers when the colour of such a product is intense yellow or orange or red. However, at the same time these type of products have been found by the applicant to be excellent vehicles of the daily intake of amounts of statins sufficient to obtain a blood LDL-cholesterol lowering effect.